On December 13, 2022 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that the Company has entered into a Common Stock Purchase Agreement (the "Purchase Agreement") for up to $25 million with Lincoln Park Capital Fund ("LPC"), a Chicago-based institutional investor and long-term Marker shareholder (Press release, Marker Therapeutics, DEC 13, 2022, View Source [SID1234625214]).

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Under the terms of the Purchase Agreement, LPC has committed to purchase up to $25 million of shares of the Company’s common stock at Marker’s sole discretion from time to time during a 24-month period upon satisfaction of the conditions in the Purchase Agreement, including after a registration statement registering the resale of shares to be sold to Lincoln Park under the Purchase Agreement is declared effective by the Securities and Exchange Commission ("SEC"). The price per share is set forth in the Purchase Agreement and is generally based on the market prices prevailing at the time of each sale to LPC. Marker will retain full control as to the timing and amount of any sale of shares of common stock to LPC, subject to certain limitations specified in the Purchase Agreement, including those under Nasdaq listing rules.

There is no upper limit as to the price per share that LPC may pay for future stock issuances under the Purchase Agreement, and LPC has agreed not to cause or engage in any direct or indirect short selling or hedging of Marker’s common stock. No warrants are being issued in this transaction, and the Purchase Agreement does not contain any rights of first refusal, participation rights, penalties or liquidated damages provisions in favor of any party. Marker maintains the right to terminate the Purchase Agreement at any time, at its discretion, without any additional cost or penalty. Marker anticipates using proceeds from sales of shares under the Purchase Agreement to advance Marker’s Phase 2 ARTEMIS trial of MT-401, the Company’s lead product candidate in post-transplant AML, Marker’s clinical programs in lymphoma and pancreatic cancer, and for working capital and general corporate purposes.

"We believe that this Purchase Agreement with LPC enables flexible access to capital in an efficient manner," stated Peter L. Hoang, President and CEO of Marker. "Following our recent organizational restructuring to conserve available capital, we continue to prudently manage our cash flow as we execute our Phase 1 and Phase 2 trials and work to bring novel cell therapies to cancer patients with limited treatment options."

Additional detail regarding the Purchase Agreement and related registration rights agreement is set forth in Marker’s Current Report on Form 8-K, filed today with the SEC.

The offer and sale of the securities by Marker in the above transaction have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), and have not been registered or qualified under any state securities laws, and therefore may not be offered or sold in the United States absent registration under the Securities Act or an applicable exemption from such registration requirements, and registration or qualification and under applicable state securities or "Blue Sky" laws or an applicable exemption from such registration or qualification requirements. Marker has agreed to file a registration statement with the SEC to register the resale by LPC of the shares of common stock to be purchased by LPC under the Purchase Agreement.

On December 13, 2022 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that at today’s Investor and Analyst Day event its executive management provided an overview of Ligand’s corporate structure and business following the successful spin-off of its OmniAb antibody discovery business, reviewed Ligand’s recent progress and near-term partner milestones and provided an outlook for financial growth (Press release, Ligand, DEC 13, 2022, View Source [SID1234625213]). Management also introduced 2023 financial guidance and discussed its capital deployment strategy. A webcast of the event including slides is available here.

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Highlights of today’s event held in-person in New York City and virtually included the following:

Business Model and Growth Drivers

Management reviewed Ligand’s business model and the ongoing diversification of its partnership portfolio. Ligand shares in the promise of the biopharmaceutical industry through royalty economics earned from providing development capital and access to its platform technologies.
Management reviewed its capital deployment strategy, which is focused on providing developmental capital and acquiring scalable platform technologies, and noted that current market conditions have created a substantial number of M&A opportunities.
Today Ligand has economic rights to more than 100 programs being developed or commercialized by nearly 100 different partners. Ligand spotlighted the most advanced late-stage assets in its portfolio and reviewed 10 potential major pipeline events expected in 2023, including:
FDA approval of Travere’s Sparsentan for the treatment of IgA nephropathy;
NDA submission of Verona’s Ensifentrine for the treatment of COPD;
EMA approval of Jazz’s Rylaze for the treatment of ALL/LBL;
FDA approval of Novan’s Berdazimer gel for the treatment of molluscum;
Late-stage clinical data for Palvella’s QTORIN in pachyonychia congenita, MLM and Gorlin syndrome;
Late-stage clinical data for Marinus’ ganaxolone in refractory status epilepticus;
Phase 2b data for Vikings’ VK2809 in NASH;
FDA Therapeutic Equivalence rating of Alvogen’s teriparatide injection in reference to Forteo.
Management outlined the development status and market landscape of select pipeline programs including Travere’s Sparsentan, Verona’s Ensifentrine and Novan’s Berdazimer gel.
Management reviewed Ligand’s role in the manufacturing of Veklury (remdesivir) to treat COVID-19 and highlighted that cumulative sales of Captisol related to COVID between 2020 and 2022 are expected to exceed $300 million, providing Ligand with significant non-dilutive capital.
Management provided an overview and update on the Captisol and Pelican Expression Technology platforms, including recent partner progress.
Management reviewed the recently completed spin-off of OmniAb and the strength each company has as independent publicly traded companies.
Management discussed how intellectual property is fundamental to Ligand’s revenue streams, how innovations in its platform technologies can drive licensing opportunities, and the means it uses to protect potential returns in its transactions.
Ligand highlighted progress in Environmental, Social and Governance (ESG) initiatives, including a $2.5 million solar investment and water savings from innovative manufacturing techniques, and its continued future focus on such initiatives.
Financial Overview and Outlook

Management discussed Ligand’s strong revenue growth and its expectations for continued topline growth. Revenue growth has contributed to significant cash flow and earnings.
The company introduced 2023 financial guidance, as follows:
Total core revenue of $118 million to $122 million, comprised of $72 million to $76 million from royalties, $21 million from sales of Captisol (excluding COVID-related sales) and $25 million from contract revenue;
Total cash operating expenses of $46 million;
Adjusted diluted EPS of $3.10 to $3.30.
Ligand estimates that at the end of 2022 it will have $150 million of cash and investments available to fund its M&A initiatives.
Adjusted Financial Measures

The Company reports adjusted net income and adjusted net income per diluted share in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company’s financial measures under GAAP include share-based compensation expense, non-cash interest expense, amortization related to acquisitions and intangible assets, changes in contingent liabilities, mark-to-market adjustments for amounts relating to its equity investments in public companies, excess tax benefit from share-based compensation, gross profit for Captisol sales related to COVID-19, net of tax, transaction costs and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included in its earnings releases for the year ended December 31, 2021 and the third quarter ended September 30, 2022, available here. However, the Company does not provide reconciliations of such forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in contingent liabilities, changes in the market value of its investments in public companies, share-based compensation expense and the effects of any discrete income tax items. Management has excluded the effects of these items in its adjusted measures to assist investors in analyzing and assessing the Company’s past and future core operating performance. Additionally, adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

On December 13, 2022 PharmaJet, a company that engineers precision delivery systems that overcome the challenges of vaccine and pharmaceutical companies, reported that their partner Immunomic Therapeutics received FDA fast track designation (FTD) for the clinical study of their plasmid DNA vaccine ITI-3000 in patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer (Press release, Immunomic Therapeutics, DEC 13, 2022, View Source [SID1234625212]). Enrollment is in progress for the phase 1 study that exclusively uses the PharmaJet Stratis Needle-free Injection System (NFIS).

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"The FDA’s decision to grant FTD underscores the potential for the ITI-3000 program to address a serious unmet need and serve as a meaningful therapeutic option for patients with Merkel cell carcinoma," stated Dr. William Hearl, Chief Executive Officer of ITI. "We are committed to unlocking the full potential of ITI-3000 in patients with this aggressive form of skin cancer. We expect to report top-line data from our ongoing phase 1 trial of ITI-3000 in MCC patients next year and look forward to working closely with the FDA on a potential next phase clinical study design, while simultaneously continuing dialogue with possible partners." The PharmaJet Stratis NFIS was chosen due to its ability to precisely deliver the vaccine to the intramuscular tissue layer.

"We are pleased that our partner Immunomic Therapeutics has received fast track designation for this important DNA therapeutic for aggressive skin cancer," said Chris Cappello, President and CEO, PharmaJet. "The PharmaJet NFIS have been used successfully in administration of therapeutics for the prevention or treatment of lymphoma, advanced solid tumors, HPV and other oncology applications."

On December 13, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported patient dosing in its ongoing Phase 1b/2a IMX-110 monotherapy clinical trial (Press release, Immix Biopharma, DEC 13, 2022, View Source [SID1234625211]). This is the fifteenth patient dosed with IMX-110 to-date. IMX-110 clinical trial data is expected to be released on a rolling basis beginning in Q1 2023; once dosing begins, patients undergo CT scans every 8 weeks to assess tumor response to IMX-110. IMX-110 monotherapy and IMX-110 combination clinical trial with Beigene/Novartis anti-PD-1 tislelizumab are enabled by newly manufactured, scaled-up IMX-110 GMP batches produced using our proprietary process.

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"We are thrilled to accelerate our efforts to bring IMX-110 to patients after scaling-up manufacturing of IMX-110," said Ilya Rachman, MD PhD, CEO of ImmixBio. "Key opinion leaders at our 5 clinical trial sites are excited to bring IMX-110 to their adult and pediatric cancer patients as a monotherapy and as a combination with Beigene/Novartis anti-PD-1 tislelizumab."

About IMX-110

The U.S. Food and Drug Administration ("FDA") approved orphan drug designation ("ODD") for IMX-110 in soft tissue sarcoma. The FDA also approved Rare Pediatric Disease Designation ("RPDD") for IMX-110 for the treatment of rhabdomyosarcoma, a life-threatening form of cancer in children. RPDD qualifies Immix Biopharma to receive fast track review, and a priority review voucher ("PRV") at the time of marketing approval of IMX-110. PRV holders can benefit from an expedited six-month review of a new drug application for any disease by the FDA. IMX-110 is currently being evaluated in a phase 1b/2a clinical trial in patients with advanced solid tumors. Learn more at www.immixbio.com/iMX-110

On December 13, 2022 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported that the United States Patent and Trademark Office (USPTO) recently issued two new patents related to the company’s novel self-amplifying mRNA (samRNA) vaccine platform technology (Press release, Gritstone Oncology, DEC 13, 2022, View Source [SID1234625210]).

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U.S. Patent No. 11,504,421 includes claims covering Gritstone’s individualized cancer vaccine candidates (GRANITE). U.S. Patent No. 11,510,973 includes claims covering antigen-encoding samRNA vectors and has broad applicability across Gritstone’s candidates in oncology and infectious disease.

"Self-amplifying mRNA (samRNA) is increasingly being recognized for its benefits over first-generation mRNA, and our new patents reflect the leadership position we believe we have established in this rapidly growing space," said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone. "Gritstone’s samRNA vectors enable extended duration and magnitude of antigen expression, in an immunostimulatory context, which together can drive more potent and durable induction of neutralizing antibodies and T cell immunity. In addition, Gritstone’s samRNA vectors allow for large cassettes, providing substantial target antigen capacity and flexibility. The clinical data we have shared to date support the potential broad application and powerful impact of this technology, and we look forward to harnessing these inherent capabilities as we further advance and develop samRNA therapeutics and prophylactics for oncology and infectious diseases."

These new patents are part of an expanding IP portfolio for Gritstone including samRNA and EDGE, the company’s proprietary antigen identification platform (EDGE: Epitope Discovery for GEnomes). Gritstone currently has eight applications granted or allowed in the United States, and approximately 300 patent applications pending in the United States and other jurisdictions.

"These patents demonstrate our commitment to developing samRNA vaccines, which have had a core role in our early oncology programs (GRANITE and SLATE) and more recently as we have expanded into infectious diseases, including our SARS-CoV-2 (CORAL) program," Andrew Allen, M.D., Ph.D. commented.

About Self-amplifying mRNA (samRNA)
Self-amplifying mRNA (samRNA) is a platform technology that has been demonstrated to be well-tolerated clinically, robustly immunogenic, scalable and widely applicable in early-stage clinical studies. Like traditional mRNA vaccines, samRNA vaccines use the host cell’s transcription system to produce target antigens to stimulate adaptive immunity. Unlike traditional mRNA, samRNA replicates once in the cell, creating copies of the original strand of RNA. Potential benefits of samRNA include extended duration and magnitude of antigen expression, strong and durable induction of neutralizing antibody and T cell immunity (CD4+ and CD8+), dose sparing and the potential to develop a refrigerator stable product. Gritstone bio is evaluating its samRNA within its oncology and infectious disease programs.

About Gritstone EDGE (Epitope Discovery for GEnomes Platform)
Gritstone EDGE is a proprietary epitope discovery platform used to discover and identify the epitopes to induce immune response for protective or therapeutic benefit. In oncology, Gritstone uses EDGE to identify those neoantigens most likely to present on a cell surface, thus making treatment visible to T cells. In infectious disease, Gritstone uses EDGE to identify fragments of viral proteins displayed on the cell surface. Once identified, Gritstone then delivers its novel vaccine candidates (self-amplifying mRNA) to these optimal targets to drive neutralizing antibody and T cell immune response. To date, Gritstone EDGE has been trained with millions of HLA-peptides and demonstrated positive predictive values of over 70%. Gritstone EDGE is patented, and results from early studies were published in Nature Biotechnology in 2018.